A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions. (TANSEI)

April 25, 2023 updated by: Fundación EPIC
This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective registry is intended to analyze clinical outcomes in patients treated with TANSEI stent in patients with complex coronary lesions .

Study Type

Observational

Enrollment (Actual)

501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Hospital General Universitario
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Ciudad Real, Spain, 13005
        • Hospital General Universitario De Ciudad Real
      • Coruña, Spain, 15006
        • Hospital Universitario de A Coruna
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Gijón, Spain, 33394
        • Hospital Universitario de Cabueñes
      • Huelva, Spain, 21005
        • Hospital General Juan Ramon Jimenez
      • Las Palmas De Gran Canaria, Spain, 35010
        • Hospital Universitario de Gran Canaria Dr. Negrin
      • León, Spain, 24001
        • Hospital Universitario de Leon
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Agusti
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen Arrixaca
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdcilla
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
    • LA Coruña
      • Santiago De Compostela, LA Coruña, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with de novo native and complex coronary artery lesions, candidate to undergo revascularisation with a coronary device.

Description

Inclusion Criteria:

  • Age> 18 years.
  • With indication of percutaneous revascularization.

  • Complex coronary lesion defined as:

    • Left main lesion AND/OR
    • Lesion located at a major bifurcation (side branch >2mm) AND/OR
    • Lesion located in a small vessel (<2.5 mm reference diameter by visual estimation) AND/OR
    • Lesion length > 35 mm
  • Informed consent signed.

Exclusion Criteria:

  • Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention).
  • Life expectancy of the patient under 1 year.
  • Patients included in other studies or clinical trials.
  • Clinical decision that excludes the use of drug-eluting stents.
  • Confirmed allergy to aspirin and / or thienopyridines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary Artery Disease (CAD)
Device: TANSEI stent
stenting with the TANSEI sirolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
Time Frame: 12 months
The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
12 months
Efficacy.The incidence of clinically driven target lesion revascularization.
Time Frame: 12 months
The incidence of clinically driven target lesion revascularization (TLR).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All death.
Time Frame: 12 months
All death.
12 months
Cardiac death.
Time Frame: 12 months
Cardiac death.
12 months
Target Vessel revascularization.
Time Frame: 12 months
Target Vessel revascularization.
12 months
Target lesion revascularization.
Time Frame: 12 months
Target lesion revascularization.
12 months
Stent thrombosis (ARC definite/probable).
Time Frame: 12 months
Stent thrombosis (ARC definite/probable).
12 months
Major bleeding event (BARC type 2-5).
Time Frame: 12 months
Major bleeding event (BARC type 2-5).
12 months
Stroke.
Time Frame: 12 months
Stroke.
12 months
Procedural success.
Time Frame: 12 months
Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment).
12 months
Rate of patients with DAPT
Time Frame: From 1 to 6 months
Rate of patients with DAPT
From 1 to 6 months
Rate of patients with DAPT
Time Frame: From 6 to 12 months
Rate of patients with DAPT
From 6 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2020

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIC08-TANSEI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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